Food and Drug Administration import alerts affecting the following have been newly issued or modified in the past week.
- antibiotics from Canada
- apple juice products
- aquacultured shrimp and prawn products from peninsular Malaysia
- candy-coated fennel seeds from India
- clay cooking pots from Mexico
- cocoa beans from Brazil, Indonesia, and Malaysia
- confectionery products containing non-nutritive components
- cucumbers from Mexico
- dates from China, Hong Kong, and Saudi Arabia
- dietary supplement products
- dried or pickled finfish from Thailand
- electronic nicotine delivery systems from China
- external penile rigidity devices
- eye makeup from China
- fish/fishery products from foreign processors not in compliance with seafood HACCP
- fresh produce that appears to have been prepared, packed, or held under insanitary conditions
- frog legs from China
- frozen shrimp from India
- fruit juice drinks from Thailand
- Greek-style yogurt drinks from China
- low-acid canned foods and acidified foods
- mackerel from Vietnam
- medical instruments from Pakistan
- organic gokhru powder from India
- papad and farfar wafers from India
- prunes from Argentina
- ready-to-eat food products that appear to have been prepared, packed, or held under insanitary conditions
- rice flakes from China
- topical/external bandages, dressings, gauzes/sponges, and cotton pads
- unapproved human growth hormone
- vegetable protein products from China for animal or human food use
- white ginseng powder from China
Import alerts inform FDA field staff that the agency has enough evidence or other information to allow a product that appears to be in violation of FDA laws and regulations to be detained without physical examination at the time of entry. Import alerts may cover products from designated countries or areas (including from all foreign countries), manufacturers, or shippers.
Firms and/or products on the “red list” of an import alert are subject to DWPE, while firms and/or products on the “green list” are not because they have met the criteria for exclusion. Some import alerts include a “yellow list” of firms, products, and/or countries subject to intensified surveillance because the nature of the violations may warrant further field examinations of individual entries and/or additional analyses. In addition, depending on the specific import alert, shipments of products subject to DWPE may still be imported into the U.S. if the importer has demonstrated that the shipment is in compliance.
If a product is detained without physical examination the importer has the right to provide evidence to the FDA in an attempt to overcome the appearance of the violation. If no such evidence is submitted, or if the evidence provided is insufficient, the product will be subject to refusal of entry into the U.S.
For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.
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